Research Administration

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https://jscholarship.library.jhu.edu/handle/1774.2/38696

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ASSESSMENT OF A CLINICAL TRIALS COMPLEXITY RATING TOOL FOR WORKLOAD PLANNING IN ONCOLOGY CLINICAL TRIALS
(2023-12) Fuentes, Carla
The institutional vetting and assessment of clinical trials may contain many procedural variables in its respective process. These procedural variables may be related to the size of the institution, the size of the department or even the hierarchy of the department’s decision-making personnel. Regardless of the method an institution elects to utilize, there are some factors that should be considered at the crux of the review process. These factors should include the ability to objectively quantify and score a clinical trial’s workload and complexity. The selection of appropriate clinical trials by an institution plays a valuable role on multiple levels. Overall, it ensures an efficient study start-up process along with the confirmation that the trial can be conducted successfully. This may positively affect stakeholder interest the institution’s clinical trials department; moreover, it may also have the capability also positively affect research coordinator engagement and retention. Incorporating a complexity and workload measurement tool to a present clinical trials assessment process may facilitate such procedural efficiencies and staff safeguarding. Through the conduction of this capstone project, procedural improvements in the existing institutional vetting of oncology clinical trials were provided. The specific improvements were the delivery of clinical trial rating objectivity and metrics to the current assessment process through an adaptable scale and tool.
THE THREAT OF FOREIGN INFLUENCE ON THE U.S. ACADEMIC RESEARCH AND NATIONAL SECURITY: CURRENT TRENDS, BEST PRACTICES, AND FUTURE DIRECTIONS
(2023-12) Alghader, Majdi
Since 2018, the U.S. government has raised concerns about foreign influence in U.S. research threatening national security and undermining the country’s economy, science openness, academic reputation, and research integrity. Maintaining an open research environment and combating undue foreign influence is an emerging challenge that demands serious action. The purpose of this paper is to investigate the reasons behind foreign influence and discuss the most recent federal changes. Several factors have contributed to foreign influence in U.S. academic research, such as the COI, morals/ ethics, new forms of employment, new organizational structures of modern research institutions, trends of global collaborations, and the FGTPs. Federal agencies such as the NIH, NSF, and DOD have made significant changes to strengthen their policies and increase their disclosure requirements in areas such as pre-award, post-award areas, and export control; these efforts are essential to pave the way for other necessary steps from research institutions to mitigate the risk. The DOD's new screening policy and decision matrix are beneficial in reducing research security risks and inspiring research institutions to create similar matrices using the DOD's indicators to develop risk management plans. Strict disclosure requirements and matrices to determine the risks for foreign influence are vital achievements from these federal agencies; however, more actions are required. Honesty and transparency of disclosures are critical factors. These new policies are insufficient without transparency in the disclosure process because the disclosure of these activities falls under researchers' discretion and their perception of transparency; thus, due to the complexity of this issue and the importance of global research collaborations, there is a need for a global academic unified digital system to serve as a real-time database for current employment and appointments of key researchers listed in research protocols. Universities can participate in this database and disclose their researchers’ appointments and employment.
INTERNATIONAL RESEARCH COLLABORATION
(2023-11) Sweet, Aaliyah
International collaborative research incorporates cross-country groups that allocate research affairs, manage research, and encourage research outcomes to develop comprehension and encourage affirmative alterations in execution. International research can benefit a specific field, incorporating more important influence and extensive pertinence. It also allows us to enlarge research discoveries to various cultures, districts, and communities. Also, international collaborative research offers opportunities to create reciprocally advantageous connections and decipher worldwide issues. However, with international collaboration, the challenges that come with it can also increase. Utilizing responses from questionnaires and articles on international research collaborations, this project aims to display the need for educational programs that can assist research administrators with overcoming barriers to international research collaborations. The responses from the questionnaires demonstrate that research administrators want educational opportunities to gain experience in how to deal with challenges that come from international research collaborations.
A COMMENTARY ON ADVANTAGES AND CHALLENGES OF GLOBAL NORTH/GLOBAL SOUTH RESEARCH COLLABORATIONS: AN EMPHASIS ON SUB-SAHARAN AFRICAN RESEARCH INFRASTRUCTURE
(2023-08) Basnight-Brown, Dana
The literature on diversity and representation within the behavioral sciences has well established that there is an under-representation of both authors and participants from institutions and countries in the Global South. As a result, our understanding of human development and behavior is limited, such that the theories created, and the conclusions drawn are not representative of much of the global population. The aim of the current paper is to provide a commentary on some of the advantages and challenges that emerge when high income countries (HICs) partner with low/middle income countries (LMICs). For example, many LMICs have a greater research emphasis on the United Nations Sustainable Development Goals (SDGs), and often favor research projects that have a direct community benefit, aspects that are sometimes not given the same attention in research initiated by HICs. Despite the many advantages of engaging with LMIC researchers, challenges also exist. Institutional infrastructure supporting research is in a nascent stage in some locations. Space and resources at institutions is limited, and research is marginally funded by many local governments. This presents challenges to researchers in multiple ways from poor library access to the absence of a formal legal structure for data sharing agreements. In addition, ethics approvals can involve very different processes and may be costly. The following commentary will focus on established evidence-based best practices from LMIC and HIC developmental research collaborations, in addition to firsthand experience by the author across laboratory-based and field research in Sub-Saharan Africa.
BEST PRACTICES FOR PROMOTING DIVERSITY, EQUITY, AND INCLUSION IN RESEARCH STUDIES: A STUDY OF THE ROLE OF RESEARCH ADMINISTRATORS
(2023-05) Ahmed, Sameer
This capstone project identifies best practices for promoting diversity, equity, and inclusion in the recruitment and retention of research administration personnel. The qualitative research conducted within this project encourages a greater level of effort to be made in enhancing the amount of diversity in the field of RA via the publication of these findings. The recommended best practices were derived from RA professionals at higher education institutions in the U.S. whose thoughts were collected through questionnaires and interview activities. The key findings indicate that many of the recommended DEI initiatives possess low implementation costs and are not difficult to establish. However, some initiatives, such as programmatic actions, may require significant financial investment, particularly for smaller institutions. The project ultimately suggests that a balance of program-based actions and behavioral modifications has the potential to effectively increase the recruitment and retention rates of diverse RA personnel in HEIs. Further studies are required to corroborate these findings.
A CENTRALIZED APPROACH TO INCREASE PARTICIPATION AND ENGAGEMENT OF INTERNAL FUNDING OPPORTUNITIES AT CAL POLY HUMBOLDT
(2022-05) Flynn, Kacie Erin
Internally funded opportunities at California State Polytechnic University, Humboldt, consistently receive lower than anticipated engagement, while academic departments struggle with the administrative burden of outreach and promotion. This lack of a coordinated strategy and practice, results in a variety of inefficient promotional methods that result in increased administrative burden on both the applicant and coordinating staff. Eligible applicants consistently have a lack of awareness as to what internal funding is available to them as well as where, when, and how to apply. Internal funding benefits faculty in piloting new projects and helps research officers gauge the types of external opportunities that might be sought by Principal Investigators. Without some form of standardization, reinforced by a strategic effort, internal funding opportunities will continue to be overlooked and underutilized by faculty. This capstone project explores the reasons why current strategies have been ineffective and looks at better coordinated ways to engage potential applicants. Cal Poly Humboldt’s Engagement Hub will provide a centralized one-stop shop for eligible campus applicants that will become interwoven into the campus culture as a standard platform for promoting campus funding opportunities.
Securing the Pre- and Post-Award Process for Boston Children's Hospital and Collaborating Institutions
(2022-05) Guinan, Margaret
In the world of research, where there are ever-changing policies and procedures, we must adapt technically as an institution by implementing well-established procedures to ensure security, version control, auditability and reduce the administrative burden for grant staff and key stakeholders. The role of research administrators is to assist in the application process and post-award management. The job relies on the effectiveness of the systems we use. It is paramount we have set procedures in place around federally accepted electronic signatures, documentation access, and a repository for collaborative review and templates. The institution will comply with federally accepted electronic signatures by implementing DocuSign and Adobe Acrobat Pro for digital sign-off. Using a centralized platform to share information by utilizing Dropbox will reduce unnecessary email communication and ensure the correct forms are used during the pre-and post-award process. Researching alternative platforms to adopt in the department will enhance the currently used methods. This project discusses the need to unify the steps to improve the overall process and reduce the administrative strain for all research administrators and key stakeholders.
Ethical Considerations in Research Across Cultures
(2022-05) Rice, Katie
Through a review of relevant literature and institutional policies and guidelines on research ethics, this capstone project explored the effect that cultural components can have on the outcome of a project through the tendency of applying ethnocentric practices. In understanding that most U.S. institutions follow western philosophies for ethical practices, regardless of the scope of the research project or the background and cultural affiliation of research participants, it was suggested by the author that institutions utilize a questionnaire before conducting the research, as well as before working with research participants in international projects. The questionnaire focuses on common topics that are likely to address value systems across cultures. These topics include language, religion, socio-economic status, minority populations, the structure of social relationships, age of maturity, perceptions of power, concern for time, regard for material goods, display of emotions, and preferred style of communication. The intent for including these topics on a questionnaire before conducting research and working with research participants is to build cultural competency with researchers and ensure that all nuances have been addressed to better guarantee a successful research project that further minimizes unintentional harm to a research participant population. The questionnaire is presented in a way that encourages institutions to utilize the questionnaire in various ways and apply the information in different aspects of a project, depending on the needs of the institution and the project.
Sponsored Research Feasibility Checklist: A Guide for Research Operation Managers
(2022-05) Galvis, Edshelee M.
Feasibility assessment of a clinical trial is one of the first steps institutions should take to ensure they have adequate patient population, staff, space, and resources to conduct a proposed clinical research project. During feasibility, timelines are initially established which may impact start-up and enrollment if not properly estimated. A detailed feasibility study, at the site level, integrating department leads and the clinical trial team should always be performed prior to accepting site participation in clinical trials. Conducting a detailed, streamlined, and efficient clinical trial feasibility study, with a step-by step guide, may positively impact the overall study start-up process at the clinical research site by preventing delays and loss of revenue throughout the research cycle. Thorough feasibility may also benefit the institution by providing historical information related to performance and areas for improvement. If performance metrics become the future of site selection, thorough site feasibility may be one of the most significant performance drivers. Therefore, this project has been conducted to provide additional resources which may be used to conduct feasibility meetings. The sponsored research feasibility checklist provided with this project provides research operation managers, or feasibility leaders, with a tool which includes a step-by-step methodology. The checklist also includes the ability to capture metrics and contains a list of topics and considerations which may be used to guide the feasibility process.
A Quick Start Guide to Setting Up Internal Funding Grant Programs
(2022-05) Vassileva-Clarke, Vessela A.
Today’s universities are not only places to teach and learn; they often serve as hubs of basic and applied research and even as hubs of technology development and commercialization. To help faculty secure research funding for these activities, many universities establish and run internal funding programs, usually referred to as seed funding programs, intramural grants programs, resource allocation programs or institutional investments. Research administrators at the central or unit level are often asked to design and run these programs, in addition to their main responsibilities related to extramural research funding, and without the necessary tools and training needed to successfully fulfil the new responsibilities. This lack of resources, which in a concise and easy to follow format provide sufficient guidance to university research administrators on the core processes and considerations for setting up internal grants programs, can be addressed by the creation of a quick start guide. The objective of this capstone project is to help fill the identified resource gap by developing such a guide. To do so, the author of the capstone project answers questions about the major types of existing internal funding programs and the type of activities they support; the main phases of an internal funding program cycle and the steps necessary to complete each of these phases; and major considerations before establishing a new program or opening a new cycle of an existing internal funding program. The answers are summarized and organized in A Quick Start Guide to Setting up Internal Funding Grant Programs. The Guide serves to support an efficient, effective and consistent process for establishing and running multiple cycles of a college or university internal funding program.
Enhancing Compliance through Annual Purchasing and Effort Allocation Training
(2022-05) Shelton, Amy E.
Recipients of grant funding must ensure compliance with grant guidelines through effective internal controls and oversight. As such, recipients are responsible for establishing, monitoring, and improving processes to ensure that funded grants are conducted according to the terms of the awards. Through this capstone project, an online annual presentation was created for purchasing and effort allocation training of the faculty and staff in the Division of Clinical Pharmacology at Vanderbilt University Medical Center. The creation of this training was a necessary addition to effective internal controls established within the Management Action Plan created in response to the 2021 Internal Audit of the Divisions of Clinical Pharmacology and Genetic Medicine in the Department of Medicine. Within the Management Action Plan, a commitment was made to retrain all faculty and staff in the areas of purchasing and effort allocations and to reestablish the role of the Division Compliance Experts. The presentation accomplished both objectives in addition to providing guidance for purchases of electronic equipment and software. This additional training will add a level of internal controls needed to ensure understanding of grant guidelines at all levels.
Leadership in Research Insights and Business Intelligence: A Conceptual Framework and Guide
(2022-05) Shoemaker, Alexis
Research insights and business intelligence are the cornerstones of informed business decisions. When these functions within a company are led effectively and work well, the value speaks for itself. To address the challenge of leadership, especially change leadership through programmatic growth on research insights and business intelligence teams, this capstone project provides a conceptual and theoretical framework and guide for effective leadership. Specifically, this capstone project elucidates concepts including leadership fundamentals, leadership theories, change theories, guiding principles and visioning, communication, team development, strategic planning, building capacity, and reflexivity. This capstone project is intended to be a guide for effective incorporation of theory-based actions to augment a leader’s existing praxis and inspire productive and rewarding reflexive analysis of current leadership practices.
How to Establish a Supportive Research Administration Ecosystem for Remote Work During and Post COVID-19
(2021-12) Bendeck, Jose
The emergence of the novel coronavirus (SARS-CoV-2) has been the catalyst for another change agent in the research enterprise. This virus has forced most research administrators to shift to working from home. This forced flexibility in research administration work has presented both challenges and opportunities. The author's capstone project investigates the requirements of working from home (WFH) for research administrators. This research is accomplished by evaluating survey data, global studies on remote work, journal articles, and the author’s personal experiences transitioning to remote work. The results of this project delineate best practices for establishing a supportive research administration ecosystem during and post COVID-19.
Establishment of an Electronic Grants Management System at Kamuzu University of Health Sciences: Increasing Research Administration Efficiency and Promoting Research Visibility
(2021-12) Mungoni, Palinji
The conduct of research has undergone a significant change over the years, and the idea of an isolated scientist making discoveries is now a far-fetched notion. The current societal problems require a multidisciplinary approach, and scientists are often employees of organizations and not mere enthusiasts. Research funding is mainly from the government or companies with shareholders. The agency relationship exists in these institutions and makes officers tasked with managing these institutions risk-averse due to fiduciary duty. They are held accountable for decisions they make on behalf of their principals, who always require transparency. Electronic project management tools allow researchers and institutions to manage these complex and often competing requirements. This paper discussed considerations for selecting an electronic research administration system in a resource-constrained setting. The reviewed considerations were necessary because such systems were costly to develop, procure and implement. The alternative proposed was web-based project management systems with flexible pricing options, highly configurable, and easy to use.
Guidelines and Proposed Policies for Pre-Award Processes Pertaining Industry Contracts and Federally Funded University-Industry Collaborations
(2021-12) Carrano, Andres Leonardo
This project seeks to establish a template for the pre-award processes regarding sponsored industry collaborations at Fairfield University. As the institution is preparing to move from an M1 (large programs) Master’s institution to a Doctoral Professional University (D/PU), there is a pressing need for the Office of Contracts and Grants to incorporate policies and procedures that facilitate the increase in sponsored research activity. The School of Engineering at Fairfield University is well-positioned to expand the amount and diversity of its industry contracts but lacks mechanisms and templates to navigate the complexities of the traditional terms and conditions, in particular regarding intellectual property, human subjects, NDAs, publishing limits, as well as flow down clauses. A gap analysis reveals several deficiencies and areas for improvement that need addressing. Further investigation reveals four areas that are amenable due to their low complexity, ease of implementation, and potential for significant impact. These include: (i) a lack of templates to execute industry contracts (and an acute need for rapid agreements), (ii) signature authorities and amounts which are not research specific; (iii) non-standard and outdated approval routing processes; and (vi) lack of faculty training on research conduct, processes, and administration. A recommendation in each one of the improvement areas is developed with consideration to potential obstacles during implementation.
Onboarding New Research Staff Through Asynchronous Learning
(2021-11) Miranda, Alejandra
Onboarding processes have become standard best practice across organizations and businesses when it comes to training new employees. These processes have proven to be one of the most important factors that employers can implement at an early stage of employment to ensure employees understand their new role and how they fit within the organization. Establishing an effective onboarding process can increase employee productivity and can also help the new employee build confidence to start supporting their new team at a faster rate. Organizations have been utilizing onboarding processes for new employees for decades. Most recently, organizations have recognized the need to modify their onboarding processes to include new methods for training and orientating new research staff, such as asynchronous learning tools. These new methods can include building a repository to make these tools accessible to employees. As such, this Capstone Project describes the need for asynchronous onboarding sessions, why this is important, and the design and development of new onboarding processes that can be utilized by organizations in need of updating their onboarding process.
A Financial Review Checklist: Supporting Best Practices in Financial Management
(2021-12) Fong, Winnie
Institutions of higher education that receive federally funded grants and cooperative agreements should have internal controls and trained personnel to fulfill various roles and responsibilities in order to comply with the Uniform Guidance as incorporated by each federal grant-making agency, along with the award terms and conditions. Research administrators are an important part of maintaining internal controls because they monitor and review expenditures, retain proper documentation, take action on any administrative requirements, and communicate directly with the principal investigator to resolve any issues. These responsibilities are all necessary to ensure that the awards are properly managed and protected against audit risk. The greater objective is to ensure accountability in the use of taxpayer dollars to stakeholders like the federal government and general public. The goal of this project is to develop a resource that would increase the efficacy and efficiency of research administrators performing financial management duties. The result was the creation of a sponsored projects financial review checklist that provides guidance and suggests best practices to handling common financial management issues and high risk audit items. The literature review provided many sources such as institutional closeout checklists that reflected common financial management issues, and audit reports from the federal inspector general that highlighted compliance areas that continue to be audit risks for institutions of higher education. The information was implemented into the checklist, so research administrators could use it as guidance to perform a consistent and thorough financial review.
Filling Training Deficits in Proposals (S2S) Through Pre-Recorded Instructional Tutorial Videos
(2021-05) Arceneaux, Lyndal
With the field of research administration being a large and ever-changing topic, it can be disorienting and frustrating for research administrators to be presented with new information or new processes, particularly without the appropriate tools and resources. This Capstone project aims to fill a gap or deficit in knowledge and understanding of the Cayuse-developed System-to-System (commonly referred to as S2S) program Proposals (S2S) for the pre-award staff at Texas A&M University Sponsored Research Services (SRS) through the production of pre-recorded tutorial videos. The author created two tutorial videos, less than ten minutes in length, which include step-by-step instructions for topics including importing subaward data and completing the prime application budget. The first video entitled Cayuse Proposals (S2S) - Import Subaward via Completed R&R Subaward Budget PDF provides instruction on importing subaward data to the prime application by uploading a completed Research and Related (R&R) Subaward Budget PDF form. The second video entitled Cayuse Proposals (S2S) – R&R Budget: Escalation/Replication and Manage Key Persons provides instruction on completing the prime proposal R&R Budget form by utilizing the tools and functionality provided by Cayuse in Proposals (S2S). These topics were determined to be those with the greatest unfamiliarity by polling the pre-award staff at SRS. The tutorial videos were made readily accessible to pre-award staff by utilizing YouTube for video publication, and the SRS website for organization of the collective links.
A Guide to Compliance with the Single IRB Mandate: Making the Best Choices for Your Institution
(2021-05) Watson, Hershea
The National Institute of Health (NIH) rolled out the new single IRB (sIRB) on January 25, 2018. The single IRB allows institutions that participate in multi-site studies to be the overseers of the institutional review board of human subject participants. Prior to this rollout, most sites with multiple studies had their own IRB office conduct an independent review of studies that involved human subject research. The NIH realized that most sites submitted an application to the review board for the same study, which prompted their introduction of the single IRB. In this Capstone Project, the author developed a training guide to address researchers' questions regarding multi-site studies and the submission of human subject protocols. The revised human subject regulations determined that only specific studies that include non- exempt human subject research using funds from the NIH will be reviewed and considered for a single IRB protocol. The author of this Capstone Project developed several flow charts and scope of project guidelines that will provide researchers with the necessary information to successfully submit their multi-site applications to the NIH Institutional Review Board in a manner that will suit their project’s and institution’s best interests.
Designing a Research Administration Shared Service Center
(2021-05) Jenkins, Tonya L.
Institutions of higher education are part of a movement to increase efficiency, become more cost-effective, and provide consistent service quality. The University of North Carolina at Chapel Hill is no different and developed a strategic framework that included a vision to be the leading global public research university in America. This framework, The Blueprint for Next, included a component for Optimizing Operations to improve administrative functions. Research administration was not exempt from this initiative and as such, the Office of the Vice Chancellor for Research took this as an opportunity to provide enhanced service, improved compliance, and better staff opportunities under a shared service model. This Capstone Project describes the design process for a shared service support infrastructure for research administration that can be implemented as a pilot for feasibility purposes.

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